Hybrid spinal plates

ABSTRACT

Various spinal plating systems for use in treating spinal pathologies are provided. In certain exemplary embodiments, the spinal plating systems can be configured to allow a surgeon to select a bone screw construct having a particular range of motion for attaching a spinal plate to bone as needed based on the intended use. In one exemplary embodiment, the spinal plating system includes a first bone screw that is polyaxially movable relative to the spinal plate, and a second bone screw that has a range of motion that is substantially limited to a single plane.

BACKGROUND

For a number of known reasons, bone fixation devices are useful for promoting proper healing of injured or damaged vertebral bone segments caused by trauma, tumor growth, or degenerative disc disease. The fixation devices immobilize the injured bone segments to ensure the proper growth of new osseous tissue between the damaged segments. These types of bone fixation devices often include internal bracing and instrumentation to stabilize the spinal column to facilitate the efficient healing of the damaged area without deformity or instability, while minimizing any immobilization and post-operative care of the patient.

One such device is an osteosynthesis plate, more commonly referred to as a bone fixation plate, that can be used to immobilize adjacent skeletal parts such as bones. Typically, the fixation plate is a rigid metal or polymeric plate positioned to span bones or bone segments that require immobilization with respect to one another. The plate is fastened to the respective bones, usually with bone screws, so that the plate remains in contact with the bones and fixes them in a desired position. Bone plates can be useful in providing the mechanical support necessary to keep vertebral bodies in proper position and bridge a weakened or diseased area such as when a disc, vertebral body or fragment has been removed.

Such plates have been used to immobilize a variety of bones, including vertebral bodies of the spine. These bone plate systems usually include a rigid bone plate having a plurality of screw openings. The bone plate is placed against the damaged vertebral bodies and bone screws are used to secure the bone plate to the spine, usually with the bone screws being driven into the vertebral bodies.

Bone screws can be supported in a spinal plate in either a rigid or a semi-rigid fashion. In a rigid fashion, the bone screws are not permitted to move angularly relative to the plate. Conversely, in a semi-rigid fashion, the bone screws can move relative to the plate. The use of rigid and semi-rigid bone screws allow the surgeon to select the appropriate bone screw based on the particular treatment. While current plating systems can be effective, they typically require the use of different plates to obtain the desired bone screw fixation.

Accordingly, there remains a need for an improved plating system that allows the surgeon to use a single plate and to select between various types of bone screw fixation.

SUMMARY

Disclosed herein are various exemplary spinal plating systems for use in treating spinal pathologies. The spinal plating systems can be configured to allow a surgeon to select a bone screw construct having a particular range of motion for attaching a spinal plate to bone as needed based on the intended use. In one exemplary embodiment, the spinal plating system includes a first bone screw that is polyaxially movable relative to the spinal plate, and a second bone screw that has a range of motion that is substantially limited to a single plane.

While the exemplary spinal plating systems can include a spinal fixation plate having virtually any configuration, in one exemplary embodiment the spinal plate includes a thru-bore formed therein that is adapted to interchangeably receive a first bone engaging fastener such that a shank of the first bone engaging fastener is movable in more than one plane of motion relative to the spinal plate, and a second bone engaging fastener such that movement of a shank of the second bone engaging fastener relative to the spinal plate is substantially limited to a single plane of motion.

While the thru-bore in the spinal plate can have a variety of configurations, one exemplary thru-bore includes a proximal inner wall and a distal inner wall that differ in shape relative to one another. The proximal inner wall can, for example, be substantially symmetrical about a common axis of the thru-bore, and the distal inner wall can, for example, be substantially asymmetrical about the common axis. In another exemplary embodiment, at least a portion of the distal inner wall can extend at an angle relative to a central axis of the thru-bore. One exemplary angle is in the range of approximately 1° to approximately 10°. In another exemplary embodiment, the proximal inner wall of the thru-bore can be substantially spherical, and the distal inner wall of the thru-bore can be oblong. The oblong inner wall can have a maximum extent and a minimum extent that is less than the maximum extent. Where the spinal fixation plate includes opposed proximal and distal ends, and opposed lateral sides extending between the opposed proximal and distal ends, in one embodiment the minimum extent can extend in a proximal-distal direction, and the maximum extent can extend in a medial-lateral direction. In another embodiment, the maximum extent can extend in a proximal-distal direction, and the minimum extent can extend in a medial-lateral direction.

In yet another exemplary embodiment of the present invention, first and second bone engaging fasteners are provided having a shank with a head formed thereon and adapted to be received within a thru-bore in the spinal plate. The head of the second bone engaging fastener can be different from the head of the first bone engaging fastener such that the fasteners interact with a thru-bore in a spinal plate in two different orientations. While each bone engaging fastener can have a variety of configurations, in one exemplary embodiment the head of the first bone engaging fastener can have a distal portion with an extent that is substantially less than the maximum and minimum extents of a distal inner wall of the thru-bore formed in a spinal plate, and the head of the second bone engaging fastener can have a distal portion with an extent that is adapted to engage the minimum extent of the distal inner wall of the thru-bore.

In another embodiment, the spinal plate can include opposed proximal and distal ends and lateral sides extending between the proximal and distal ends. When a first bone engaging fastener is disposed within a thru-bore in the plate, a shank of the first bone engaging fastener can be movable in a proximal direction, a distal direction, a medial direction, a lateral direction, and combinations thereof. When a second bone engaging fastener is disposed within the thru-bore in the plate, a shank of the second bone engaging fastener can be substantially limited to movement in only one of a proximal direction, a distal direction, a medial direction, a lateral direction, a medial-lateral direction, and a proximal-distal direction.

An exemplary spinal plate having an insert disposed therein for receiving a first bone screw in a variable angle construct and a second bone screw in a limited angle construct is also provided. In another embodiment, the insert can be a ring-shaped member disposed within a thru-bore in the plate. The ring-shaped member can have a variety of configurations, for example it can include a split formed therein such that an extent of the ring-shaped member is adjustable. In one exemplary embodiment, the ring-shaped member can include an outer surface having a shape that complements a shape of an inner surface of the thru-bore, and an inner surface having at least a portion that is asymmetrical about an axis of the thru-bore in the insert. By way of non-limiting example, at least a portion of the inner surface of the thru-bore can have an oblong shape. In another embodiment, the ring-shaped member can be adapted to be disposed within the thru-bore in the spinal plate in a plurality of positions. The ring-shaped member can include an alignment mechanism adapted to align the ring-shaped member in one of the plurality of positions in the thru-bore in the spinal plate. By way of non-limiting example, the alignment mechanism can be at least one protrusion formed on an external surface of the ring-shaped member. The thru-bore in the spinal plate can include at least one corresponding detent formed therein for receiving the protrusion(s) on the ring-shaped member.

An exemplary spinal plating kit is also provided. In one embodiment, the spinal plating kit includes a first bone engaging fastener having a shank with a head formed thereon, a second bone engaging fastener having a shank with a head that differs from the head of the first bone engaging fastener, and a spinal plate having a thru-bore formed therein and adapted to selectively seat the head of the first and second bone engaging fasteners. At least a portion of the thru-bore can be substantially asymmetrical about an axis of the thru-bore such that the thru-bore is adapted to allow polyaxial movement of the shank of the first bone engaging fastener, and it is adapted to substantially limit movement of the shank of second bone engaging fastener to within a single plane of motion. In one exemplary embodiment, the thru-bore in the spinal plate can include a proximal portion that is adapted to selectively seat a proximal portion of the head of the first and second bone engaging fasteners, and a distal portion that is adapted to selectively seat a distal portion of the head of the first and second bone engaging fasteners. By way of non-limiting example, the proximal portion of the thru-bore can be substantially spherical and the distal portion of the thru-bore can be substantially oblong. In another exemplary embodiment, the head of the first bone engaging fastener can include a substantially spherical proximal portion and a distal portion, and the head of the distal portion of the second bone engaging fastener can include a substantially spherical proximal portion and a substantially cylindrical distal portion having a size that is greater than a size of the distal portion of the first bone engaging fastener such that the distal portion of the head of the second bone engaging fastener is adapted to engage at least a portion of the distal portion of the thru-bore.

Exemplary methods for implanting a spinal fixation plate are also provided. One exemplary methods includes positioning a spinal fixation plate against bone. The spinal fixation plate includes a thru-bore with an insert disposed therein. The insert can have a central opening formed therethrough and defining a single plane of motion of a bone engaging fastener to be received therein. The insert can then be rotated to orient the single plane of motion in a desired direction, and a bone engaging fastener can then be inserted through the insert to attach the spinal fixation plate to bone, wherein movement of a shank of the bone engaging fastener is limited to the desired direction of the single plane of motion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of an exemplary embodiment of a spinal fixation plate having a bone screw disposed within a thru-bore formed therein and showing an exemplary range of motion of the bone screw;

FIG. 1B is an end view of the spinal plate and bone screw shown in FIG. 1A;

FIG. 1C is a side view of the spinal plate and bone screw shown in FIG. 1A;

FIG. 2A is a perspective view of the spinal plate shown in FIG. 1A having another exemplary embodiment of a bone screw disposed within a thru-bore formed therein and showing an exemplary range of motion of the bone screw;

FIG. 2B is an end view of the spinal plate and bone screw shown in FIG. 2A;

FIG. 2C is a side view of the spinal plate and bone screw shown in FIG. 2A;

FIG. 3A is a superior perspective view of another exemplary embodiment of a spinal fixation plate;

FIG. 3B is a side view of the spinal fixation plate shown in FIG. 3A;

FIG. 3C is a cross-sectional view of the spinal fixation plate shown in FIG. 3A taken across line C-C;

FIG. 3D is a cross-sectional view of the spinal fixation plate shown in FIG. 3A taken across line D-D;

FIG. 4A is a perspective view of one exemplary embodiment of a bone screw adapted to be disposed within one of the thru-bores shown in the spinal fixation plate of FIGS. 3A-3D;

FIG. 4B is an enlarged view of the head of the bone screw shown in FIG. 4A;

FIG. 5A is a perspective view of another exemplary embodiment of a bone screw adapted to be disposed within one of the thru-bores shown in the spinal fixation plate of FIGS. 3A-3D;

FIG. 5B is an enlarged view of the head of the bone screw shown in FIG. 5A;

FIG. 6A is a perspective view of an exemplary embodiment of an insert that is adapted to be disposed within a thru-bore in a spinal fixation plate;

FIG. 6B is a superior view of one embodiment of a spinal fixation plate showing the insert of FIG. 6B disposed within two thru-bores formed therein;

FIG. 6C is a superior view of the spinal fixation plate shown in FIG. 6B showing the insert of FIG. 6B disposed within two thru-bores formed therein and having two bone screws disposed therethrough;

FIG. 7 is a perspective view of another exemplary embodiment of a spinal fixation plate; and

FIG. 8 is a perspective view of yet another embodiment of a spinal fixation plate.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

In one exemplary embodiment, a spinal plating system is provided having a spinal plate with at least one thru-bore formed therein for selectively receiving at least two types of bone screws, thus allowing a surgeon to select an appropriate construct depending on the intended use. While various techniques can be used to achieve such a spinal plating system, and certain exemplary embodiments will be discussed in more detail below, FIGS. 1A-2C generally illustrate the functionality of one such exemplary spinal plating system having a spinal plate 10, a variable angle bone screw 20, and a limited angle bone screw 30. At the outset, one skilled in the art will understand that the spinal plate 10 and bone screws 20, 30 shown in FIGS. 1A-2C are merely shown for illustration purposes, and that the spinal plate 10 and bone screws 20, 30 can have virtually any configuration. By way of non-limiting example, FIG. 7 illustrates another exemplary embodiment of a spinal fixation plate that can include various features disclosed herein. A person skilled in the art will also appreciate that a variety of other fastening devices can be used in place of the bone screws 20, 30 to attach the spinal plate 10 to bone. While not shown or particularly described, the exemplary spinal plating systems disclosed herein can also include a rigid bone screw that is adapted to be disposed through a thru-bore in the plate at a fixed angle.

Referring first to FIGS. 1A-1C, one exemplary embodiment of a variable angle bone screw 20 is shown disposed within a thru-bore 12 in a spinal plate 10. The bone screw 20, various exemplary embodiments of which will be discussed in more detail below, generally includes a head 22 and a shank 24 extending from the head 22. In this exemplary embodiment, when the shank 24 of the bone screw 20 is disposed through the thru-bore 12 in the plate 10 and the head 22 of the bone screw 20 is seated within the thru-bore 12, the shank 24 of the bone screw 20 can move polyaxially relative to the plate 10. In particular, the head 22 of the bone screw 20 can pivot within the thru-bore 12 such that the shank 24 can move freely within multiple planes of motion, as indicated by the cone-shaped shaded area M_(f). The polyaxial range of motion of the bone screw 20 can vary depending on the particular configuration of the bone screw 20 and the plate 10, for example on the size and shape of the screw head 22 relative to the size and shape of the thru-bore 12, but in the illustrated exemplary embodiment the shank 24 of the bone screw 20 can move approximately 15° in all directions from a neutral axis A_(s), of the screw 20, such that the cone-shaped shaded area M_(f) has a cone angle α_(f) of about 30°. A person skilled in the art will appreciate that the range of motion can be less than or substantially greater than 15° depending on the intended use. For example, the shank 24 of the bone screw 20 can move approximately 10°-20°, and in some cases greater than 25°.

Now referring to FIGS. 2A-2C, the spinal plate 10 is shown having a limited angle bone screw 30 disposed within thru-bore 12. Again, the bone screw 30, various exemplary embodiments of which will be discussed in more detail below, generally includes a head 32 and a shank 34 extending from the head 32. In this exemplary embodiment, when the shank 34 of the bone screw 30 is disposed through the thru-bore 12 in the plate 10 and the head 32 of the bone screw 30 is seated within the thru-bore 12, the shank 34 of the bone screw 30 can be substantially limited to movement within a single plane of motion relative to the plate 10. In particular, the head 32 of the bone screw 30 can be configured to pivot within the thru-bore 12 such that the shank 34 has a limited range of motion that can be substantially within a single plane, as indicated by the shaded area M_(l). The limited range of motion of the bone screw 30 can vary depending on the particular configuration of the bone screw 30 and the plate 10, for example on the size and shape of the screw head 32 relative to the size and shape of the thru-bore 12, but in the illustrated exemplary embodiment the shank 34 of the bone screw 30 can move up to approximately 5° in one direction, i.e., a total of 10° in opposed directions, substantially within a single plane from a neutral axis A_(l) of the screw 30. A person skilled in the art will appreciate that the range of motion can be less than or substantially greater than 5° depending on the intended use. For example, the range of motion of the shank 34 from the neutral axis of the bone screw 30 can be approximately 5° to approximately 15°. Moreover, while the shank 34 of the bone screw 30 can be substantially limited to movement within a single plane of motion, the bone screw 30 may toggle slightly or have some micro-motion that is outside of the plane of motion, for example, as a result of manufacturing tolerances. It will also be understood that the term “single plane of motion” is intended to generally refer to a direction of movement.

The exemplary spinal plating system shown in FIGS. 1A-3C can be achieved using a variety of techniques. FIGS. 3A-6C illustrate certain exemplary embodiments. A person skilled in the art will appreciate that the exemplary techniques used to achieve a system having two interchangeable fastening elements can be incorporated into a variety of other surgical devices, and that the exemplary spinal plating system disclosed can include a variety of other features known in the art.

Referring first to FIGS. 3A-5B, one exemplary spinal plating system is shown having a fixation plate 40 (shown in FIGS. 3A-3D), a limited angle bone screw 50 (shown in FIGS. 4A-4B), and a variable angle bone screw 60 (shown in FIGS. 5A-5B). While the spinal fixation plate 40 can have virtually any configuration and the illustrated exemplary plate 40 is merely shown for reference purposes only, the exemplary plate 40 has a generally elongate shape with opposed proximal and distal ends 40 p, 40 d, opposed lateral sides 40 a 40 b extending between the proximal and distal ends 40 p, 40 d, a superior non-bone contacting surface 40 s, and an inferior bone contacting surface 40 i. The plate 40 also includes four thru-bores 42 a, 42 b, 42 c, 42 d formed therein and extending between the superior and inferior surfaces 40 a, 40 b. The plate 40 can, however, include any number of thru-bores. The bone screws 50, 60 can also have a variety of configurations, but in the illustrated exemplary embodiment the bone screws 50, 60 generally include a head 52, 62 and a shank 54, 64 extending distally from the head 52, 62.

In this exemplary embodiment, one or more of the thru-bores 42 a, 42 b, 42 c, 42 d in the spinal plate 40 can be adapted interchangeably receive the limited angle bone screw 50 and the variable angle bone screw 60 such that the variable angle bone screw 60 can move polyaxially, as described with respect to FIGS. 1A-1C, while the limited angle bone screw 50 can be substantially limited to movement within a single plane of motion, as described with respect to FIGS. 2A-2C. In one exemplary embodiment, as shown in more detail in FIGS. 3C and 3D, one or more of the thru-bores, e.g., thru-bore 42 c, can have a proximal inner wall 43 a and a distal inner wall 43 b, and the shape of each portion of the inner wall 43 a, 43 b of the thru-bore 42 c can be adapted to interact differently with each bone screw 50, 60. In particular, in the illustrated exemplary embodiment the proximal inner wall 43 a of the thru-bore 42 c can have a shape that is complementary to the shape of at least a proximal portion of the head 52, 62 of each bone screw 50, 60, while the distal inner wall 43 b of the thru-bore 42 c can have a shape that differs from the proximal inner wall 43 a and that allows free angular movement of the variable angle bone screw 60 while limiting movement of the limited angle bone screw 50.

While the shape of the proximal inner wall 43 a of the thru-bore 42 c can vary, in one exemplary embodiment the proximal inner wall 43 a of the thru-bore 43 a can be substantially symmetrical about a common or central axis A of the thru-bore 42 c. For example, the proximal inner wall 43 a can have a substantially spherical shape. At least a proximal portion 52 a, 62 a of the head 52, 62 of each bone screw 50, 60 can also have a symmetrical shape, such as a spherical shape as shown in FIGS. 4A-5B, that complements the spherical shape of the proximal inner wall 43 a of the thru-bore 42 c. Thus, in use, the spherical proximal inner wall 43 a of the thru-bore 42 c can interchangeably seat the spherical proximal portion 52 a, 62 a of the head 52, 62 of each bone screw 50, 60, and in an exemplary embodiment the proximal inner wall 43 a does not impinge on or otherwise present movement of the proximal portion 52 a, 62 a of each bone screw 50, 60. A person skilled in the art will appreciate that while the exemplary proximal inner wall 43 a is described as having a substantially spherical shape, that the proximal inner wall 43 a can have some interruptions in the shape. For example, the proximal inner wall 43 a can include a cut-out portion to facilitate use of a locking mechanism with the plate 40, as will be described in more detail below.

The distal inner wall 43 b of the thru-bore 42 c can also have a variety of shapes and sizes, but in one exemplary embodiment the distal inner wall 43 b of the thru-bore 42 c is substantially asymmetrical about a common or central axis A of the thru-bore 42 c. For example, the distal inner walls 43 b of the thru-bore 42 c can have an oblong shape, as shown. As a result of the oblong shape of the distal inner wall 43 b, the distal inner wall 43 b can include a minimum extent D_(t1), and a maximum extent D_(t2) that is greater that minimum extent D_(t1). The minimum and maximum extents D_(t1), D_(t2) can be adapted to control movement of each bone screw 50, 60.

As shown in FIGS. 5A and 5B, the exemplary variable angle bone screw 60 has a head 62 with a distal portion 62 b that is adapted to be received within the distal portion 43 b of the thru-bore 42 c. While the shape of the distal portion 62 b of the head 62 can vary, in the illustrated exemplary embodiment the distal portion 62 b is substantially cylindrical. The distal portion 62 b can have an extent, e.g., a diameter D_(v), that is substantially less than the minimum and maximum extents D_(t1), D_(t2) of the distal portion 43 b of the thru-bore 42 c. As a result, the distal portion 62 b of the head 62 of the variable angle bone screw 60 can move in multiple directions, e.g., proximal, distal, medial, lateral, and combinations thereof, such that the shank 64 is polyaxial relative to the plate 40. A person skilled in the art will appreciate that the head 62 of the variable angle bone screw 60 does not necessarily need to include a distal portion 62 b, and that the head 62 can merely taper into the shank 64.

As shown FIGS. 4A and 4B, the limited angle bone screw 50 can also have a head 52 b with a distal portion 52 b that is also adapted to be received within the distal portion 43 b of the thru-bore 42 c. However, in an exemplary embodiment, the distal portion 52 b of the head 52 of the limited angle bone screw 50 can differ in size relative to the distal portion 62 b of the head 62 of the variable angle bone screw 60. In an exemplary embodiment, the distal portion 52 b of the head 52 of the limited angle bone screw 50 has a substantially cylindrical shape with an extent, e.g., a diameter D_(L), that is greater than an extent, e.g., a diameter D_(V), of the distal portion 62 b of the variable angle bone screw 60, that is substantially less than the maximum extent D_(t2) of the oblong distal inner wall 43 b of the thru-bore 42 c, and that is only slightly less than the minimum extent D_(t1), of the oblong distal inner wall 43 b of the thru-bore 42 c. As a result, when the head 52 of the limited angle bone screw 50 is seated within the thru-bore 42 c, the portion of the distal inner wall 43 b of the thru-bore 42 c having a minimum extent D_(t1), can engage the distal portion 52 b of the head 52 of the limited angle bone screw 50, thereby preventing movement of the bone screw 50 in the direction of the minimum extent D_(t1). The bone screw 50 can move in the direction of the maximum extent D_(t2) of the distal inner wall 43 b of the thru-bore 42 c as the maximum extent D_(t2) is greater than the extent, e.g., diameter D_(L), of the distal portion 52 b of the limited angle bone screw 50.

The direction of movement of the limited angle bone screw 50 can vary depending on the positioning of the oblong distal inner wall 43 b of the thru-bore 42 c. In other words, the minimum and maximum extents D_(t1), D_(t2) of the oblong distal inner wall 43 b of the thru-bore 42 c can extend in any direction relative to the plate 40 depending on the intended plane of motion of the limited angle bone screw 50. In one exemplary embodiment, the minimum extent D_(t1), extends in a proximal-distal direction, as shown in FIG. 3D, and the maximum extent D_(t2) extends in a side-to-side direction, also referred to as a medial-lateral direction, as shown in FIG. 3C. The limited angle bone screw 50 can thus move freely in a medial-lateral direction, but it can be substantially prevented from moving in a proximal-distal direction.

The amount of movement of each bone screw 50, 60 relative to the plate 40 can also vary, and the size of the head 52, 62 of each bone screw 50, 60, as well as the size of the thru-bore 42 c, can be used to control the amount of movement in a particular direction. By way of non-limiting example, at least a portion of the distal inner wall 43 b of the thru-bore 42 c can be positioned at an angle relative to the central axis A of the thru-bore 42 c, and the angle can be determinative of the amount of movement. In the embodiment shown in FIG. 3C, the opposed sides of distal inner wall 43 b of the thru-bore 42 c that define the maximum extent D_(t2) each extend at angle α₁, α₂ that is approximately 5° such that the limited angle bone screw 50 can move 5° in a medial direction and 5° in a lateral direction. A person skilled in the art will appreciate that each angle α₁, α₂ can vary, and that only one or both sides of the distal inner wall 43 b of the thru-bore 42 c that define the maximum extent D_(t2) can extend at an angle to control movement of the limited angle bone screw 50. Moreover, the distal inner wall 43 b of the thru-bore 42 c does not need to extend at an angle to control movement of the limited angle bone screw 50. In other exemplary embodiments, some or all of the distal inner wall 43 b can be substantially parallel to the central axis A. For example, the inner wall 43 b can have a stepped configuration such that the extent of the inner wall 43 b changes between the proximal inner wall 43 a and the distal inner wall 43 b. In other embodiments, the inner wall 43 b can include a series of steps to change the extent between the proximal and distal inner walls 43 a, 43 b. A person skilled in the art will appreciate that a variety of other techniques can be used to control movement of a limited angle bone screw 50 relative to the plate 40.

FIGS. 6A-6C illustrate another exemplary embodiment of a spinal plating construct. In this embodiment, rather than having a spinal plate with at least one thru-bore that is adapted to control movement of a variable angle bone screw and a limited angle bone screw, an insert 70 is provided for use with a spinal fixation plate. In one exemplary embodiment, the insert 70 is used with the limited angle bone screw 50 shown in FIGS. 4A-4B and the variable angle bone screw 60 shown in FIGS. 5A-5B. A person skilled in the art will appreciate that the insert 70 can be used with a variety of other fastening devices.

The insert 70 can have virtually any shape and size, but in certain exemplary embodiments the insert 70 can have a shape that is adapted to be received within a thru-bore in a spinal plate. As shown in FIG. 6A, the exemplary insert 70 is substantially ring-shaped with an outer surface 70 a and an inner surface 70 b defining a bore 72 extending therethrough. As is further shown in FIG. 6A, the exemplary insert 70 can include a split or gap 71 formed therein to allow an extent or size of the insert 70 to be adjusted as may be needed to position the insert within a thru-bore in a spinal plate.

The outer surface 70 a of the insert 70 can vary depending on the shape and size of the thru-bore which the insert 70 is adapted to be received within. In the illustrated exemplary embodiment, the outer surface 70 a of the insert 70 is substantially cylindrical, but it can have a stepped configuration as shown. The stepped configuration allows the insert 70 to be seated within a thru-bore having a corresponding stepped configuration, thus preventing the insert 70 from passing completely through the thru-bore. An exemplary embodiment of a spinal plate 80 having thru-bore 82 a, 82 b, 82 c, 82 d is shown in FIG. 6B, and as shown two inserts 70, 70′ are disposed within two of the thru-bores, e.g., thru-bores 82 b and 82 d. A person skilled in the art will appreciate that the insert 70 can be used with virtually any spinal plate, and plate 80 is merely shown for reference purposes.

The inner surface 70 b of the insert 70 can also have a variety of configurations, but in one exemplary embodiment the inner surface 70 b is adapted to receive and interact differently with a variable angle bone screw, such as bone screw 60 shown in FIGS. 5A-5B, and a limited angle bone screw, such as bone screw 50 shown in FIGS. 4A-4B. As shown in FIG. 6A, at least a portion of the inner surface 70 b of the exemplary insert 70 can be substantially asymmetrical about a common or central axis of the insert 70. In an exemplary embodiment, the inner surface 70 b is similar to thru-bore 42 c previously described in FIGS. 3A-3D and it can include a proximal portion that is substantially symmetrical about a common axis of the thru-bore 72, and a distal portion that is substantially asymmetrical about the common axis. By way of non-limiting example, the proximal portion can have an spherical shape and the distal portion can having an oblong shape such that the distal portions includes a minimum extent d_(i1) and maximum extent d_(i2) that is greater than the minimum extent d_(i1).

As previously described with respect to the thru-bore 42 c in spinal fixation plate 40, the minimum and maximum extent d_(i1), d_(i2) portions can be adapted to control movement of the bone screws 50, 60, which are shown in FIG. 6C disposed through the inserts 70, 70′ in the thru-bores 82 b, 82 d of plate 80. In an exemplary embodiment, the extent, e.g., diameter D_(v), of the distal portion 62 b of the exemplary variable angle bone screw 60 (shown in FIGS. 5A and 5B) can be substantially less than the minimum and maximum extents d_(i1), d_(i2) of the oblong portion of the inner wall 70 b of the insert 70. As a result, the distal portion 62 b of the head 62 of the variable angle bone screw 60 can move in multiple directions, e.g., proximal, distal, medial, lateral, and combinations thereof, such that the shank 64 is polyaxial relative to the plate 40. In another exemplary embodiment, the extent, e.g., diameter D_(L), of the distal portion 52 b of the head 52 of the limited angle bone screw 50 can be substantially less than the maximum extent d_(i2) of the oblong portion of the inner wall 72 b of the insert 70 and only slightly less than the minimum extent d_(i1) of the oblong portion of the inner wall 72 b of the insert 70. As a result, when the head 52 of the limited angle bone screw 50 is seated within the insert 70, the minimum extent d_(i1) portion of the inner wall 72B of the insert 70 can engage the distal portion 52 b of the head 52 of the limited angle bone screw 50, thereby substantially preventing movement of the bone screw 50 in the direction of the minimum extent d_(i1). The bone screw 50 can move in the direction of the maximum extent d_(i2) of the distal inner wall 72 b of the insert 70 as the maximum extent d_(i2) can be greater than the extent, e.g., diameter D_(L), of the distal portion 52 b of the limited angle bone screw 50.

As was previously described with respect to thru-bore 42 c in plate 40, the minimum and maximum extents d_(i1), d_(i2) of the oblong inner wall 72 b of the insert 70 can be adapted to control the intended plane of motion of the limited angle bone screw 50. For example, at least a portion of the oblong portion of the inner wall 72 b of the insert 70 can be positioned at an angle to control the range of motion of the limited angle bone screw 50. A person skilled in the art will appreciate that the shape of bore 72 in the insert 70 can have a variety of other configurations, and that the shape can be adapted in other ways to control the plane of motion of the limited angle bone screw 50 and/or the range of motion.

In another exemplary embodiment of the present invention, the insert 70 can be adapted to allow the direction of motion of the limited angle bone screw 50 to be selectively adjusted. While various techniques can be used to provide such a configuration, in one exemplary embodiment the direction in which the insert 70 is positioned within the thru-bore in the plate can be determinative of the plane of motion of the limited angle bone screw 50. For example, the maximum extent d_(i2) of the inner wall 70 b of the insert 70 can be positioned within a thru-bore 82 a-d in the plate 80 in a direction of desired movement of the limited angle bone screw 50, as the maximum extent d_(i2) portion of the inner wall can control the direction in which the limited angle bone screw 50 is allowed to move. As shown in FIG. 6A, the maximum extent d_(i2) of the insert 70 is aligned with the slit 71. Thus, when the insert 70 is disposed within one of the thru-bores 82 a-d in the plate, the slit 70 can be positioned in the desired direction of movement. A person skilled in the art will appreciate that a slit 71 is not necessary and that a variety of other techniques can be used to indicate the orientation of the insert, including, for example, indicia formed on the insert 70. Moreover, in use, the insert can be oriented as desired either before or after a bone screw is inserter therethrough.

In another embodiment, the insert 70 can include an alignment mechanism formed thereon and adapted to allow the insert 70 to be selectively aligned with the thru-bore in a desired direction of movement. By way of non-limiting example, the alignment mechanism can be one or more ridges, grooves, protrusions, detents, etc., or other features formed on the outer surface 70 a of the insert 70, and the inner surface of at least one of the thru-bores 82 a-82 d in the plate 80 can include corresponding ridges, grooves, protrusions, detents, etc., or other features formed on the inner surface thereof. The insert 70 can thus be inserted into one of the thru-bores 82 a-82 d in the plate 80 in a desired position, and the alignment mechanism can be effective to maintain the insert 70 in that position, i.e., to prevent rotation of the insert.

In certain exemplary embodiments, the insert 70 can include four protrusions (not shown) formed on the outer surface 70 a thereof, and at least one of the thru-bores 82 a-d in the plate 80 can include four corresponding detents (not shown) formed therein for receiving the protrusions. The detents or protrusions can be adapted to align the minimum and maximum extents d_(i1), d_(i2) portions of the insert 70 in a particular direction, such as a proximal-distal direction or a medial-lateral direction. As a result, the insert 70 can be disposed within the thru-bore 82 a-d in one of several orientations. In the first orientation, the slit 71, which can function as an indicator for the maximum extent d_(i2) which can be aligned with the slit 71, can be positioned toward the proximal end 80 p of the plate 80 to allow movement of the limited angle bone screw 50 in a proximal direction, a distal direction, or both a proximal and distal direction. The slit 71 can likewise be positioned in a second, opposed orientation toward the distal end 80 d of the plate 80 to likewise allow movement in a proximal direction, a distal direction, or both a proximal and distal direction. In a third orientation, the slit 71 can be positioned toward lateral side 80 a of the plate 80 to allow movement of the limited angle bone screw 50 toward lateral side 80 a, toward the opposed lateral side 80 b, or in both directions, e.g., a medial-lateral or side-to-side direction. Likewise, in the fourth orientation, the slit 71 can be positioned toward lateral side 80 b of the plate 80 to allow movement of the limited angle bone screw 50 toward lateral side 80 a, toward the opposed lateral side 80 b, or in both directions, e.g., a medial-lateral or side-to-side direction. A person skilled in the art will appreciate that a variety of other techniques can be used to allow the direction of movement of the limited angle bone screw 50 to be controlled.

While FIGS. 1A-3D and 6B-6C illustrate various embodiments of spinal fixation plates 10, 40, 50, 60, 80 having thru-bores 12, 42 a-d, 82 a-d with a generally circular configuration, the thru-bores can have a variety of other shapes. By way of non-limiting example, FIG. 8 illustrates another exemplary embodiment of a spinal fixation plate 90 having a slotted thru-bore 92 formed therein. While not shown, the slotted thru-bore 92 can include features, as previously described, to allow a variable angle bone screw, such as screw 60, to move polyaxially relative to the plate 90, and to substantially limit movement of a limited angle bone screw, such as bone screw 50, to a single plane of motion. The slotted thru-bore 92 can also allow the variable angle bone screw 60 and the limited angle bone screw 50 to translate within the thru-bore 92 to allow a position of the screw 50, 60 to be adjusted relative to the plate 90.

In other exemplary embodiments, a spinal fixation plate can be provided having a thru-bore having a configuration that is substantially opposite to the configuration of the thru-bores 12, 42 a-d, 82 a-d described above with respect to spinal fixation plates 10, 40, 50, 60, 80. In particular, while not illustrated, an exemplary thru-bore can include a proximal portion that is asymmetrical, e.g., oblong, about a central axis of the thru-bore, and a distal portion that is symmetrical, e.g., spherical shape, about the central axis. An exemplary variable angle bone screw and limited angle bone screw for use with such a thru-b ore can likewise have a reverse orientation, such that a head of the limited angle bone screw includes a proximal portion that is substantially cylindrical and a distal portion that is substantially spherical, and a head of the variable angle bone screw can be substantially spherical. The head of the variable angle bone screw does not necessarily need to include a proximal portion having any particular configuration.

While not illustrated, the various embodiments of the spinal plates disclosed herein can also include a locking or retaining mechanism for preventing bone screw backout. In one embodiment, the locking mechanism can be integrated into the screw head, as described in a U.S. patent filed on even date herewith and entitled “Locking Bone Screw and Spinal Plate System” of Gorhan et al., which is incorporated by reference herein in its entirety. In another embodiment, the locking mechanism can be integrated onto the surface of the plate. The integrated locking mechanism can be, for example, a cam that is rotatable between an unlocked position and a locked position, in which the cam is forced against the head of the bone screw to provide bone screw backout resistance. An exemplary cam-type locking mechanism is described in U.S. Pat. No. 5,549,612 of Yapp et al. entitled “Osteosynthesis Plate System,” which is also incorporated by reference herein in its entirety. Other exemplary retaining or locking mechanisms include, by way of non-limiting example, locking washers, locking screws, and bone screw covers. One skilled in the art will appreciate that various combinations of locking mechanisms can be used as well. Other exemplary locking mechanisms are disclosed in U.S. Pat. Nos. 6,331,179 to Fried et al., 6,159,213 to Rogozinski; 6,017,345 to Richelsoph; 5,676,666 to Oxiand et al.; 5,616,144 to Yapp et al.; 5,261,910 to Warden et al.; and 4,696,290 to Steffee.

One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety. 

1. A spinal plating kit, comprising: a first bone engaging fastener having a shank with a head formed thereon; a second bone engaging fastener having a shank with a head that differs from the head of the first bone engaging fastener; and a spinal plate having a thru-bore formed therein and adapted to selectively seat the head of the first and second bone engaging fasteners, at least a portion of the thru-bore being asymmetrical about a central axis of the thru-bore such that the thru-bore is adapted to allow polyaxial movement of the shank of the first bone engaging fastener when the head of the first bone engaging fastener is seated in the thru-bore, and it is adapted to substantially limit movement of the shank of the second bone engaging fastener to within a single plane of motion when the head of the second bone engaging fastener is seated in the thru-bore.
 2. The spinal plating kit of claim 1, wherein the thru-bore in the spinal plate includes a proximal portion that is adapted to selectively seat a proximal portion of the head of the first and second bone engaging fasteners, and a distal portion that is adapted to selectively seat a distal portion of the head of the first and second bone engaging fasteners.
 3. The spinal plating kit of claim 2, wherein the proximal portion of the thru-bore is substantially spherical and the distal portion of the thru-bore is substantially oblong.
 4. The spinal plating kit of claim 3, wherein the head of the first bone engaging fastener includes a proximal portion that is substantially spherical and a distal portion that is substantially cylindrical, and the head of the second bone engaging fastener includes a proximal portion that is substantially spherical and a distal portion, and wherein the distal portion of the head of the second bone engaging fastener is larger than the distal portion of the head of the first bone engaging fastener.
 5. A spinal plating kit, comprising: a spinal plate having a thru-bore formed therein; and an insert adapted to be received within the thru-bore in the spinal plate and having a central opening formed therethrough the central opening being adapted to allow polyaxial movement of a first bone engaging fastener disposed therethrough with a head of the first bone engaging fastener seated within the insert, and the central opening being adapted to limit angular movement of a second bone engaging fastener disposed therethrough with a head of the second bone engaging fastener seated within the insert relative to a central axis of the thru-bore to a single selected plane of motion when the insert is seated within the thru-bore.
 6. The spinal plating kit of claim 5, wherein the central opening in the insert includes a proximal inner wall that is symmetrical about a central axis of the thru-bore, and a distal inner wall that is asymmetrical about a central axis of the thru-bore.
 7. The spinal plating kit of claim 6, wherein the proximal inner wall is substantially spherical and the distal inner wall is substantially oblong.
 8. The spinal plating kit of claim 7, further comprising a first bone engaging fastener having a head that is adapted to rotate freely when disposed within the thru-bore in the plate with the head of the first bone engaging fastener seated within the insert, and a second bone engaging fastener having a head that is adapted to pivot within a single plane of motion when disposed within the thru-bore in the plate with the head of the second bone engaging fastener seated within the insert.
 9. The spinal plating kit of claim 5, wherein a position of the insert can be adjusted relative to thru-bore in the plate to orient the single selected plane of motion of the second bone engaging fastener. 